TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB

NCT03251196 | Unknown

• 1 other identifier: LMU-IMPH-TB Sequel-01
• Study Type: observational
• Target: 1,500
• Locations: 4 countries
• Sites: 4

Brief Summary

This is an observational cohort study. Pulmonary tuberculosis (TB) patients will be enrolled at the time of TB diagnosis and prospectively followed for at least two years after TB-treatment initiation with optional prolonged follow-up. Study visits will be performed in the study clinics or if necessary at the participant's home at pre-defined time points after TB treatment initiation. Clinical assessments, biological sample collections and collection of socio-economic data will be performed according to the pre-defined schedule of events.

Conditions

Respiratory Tract Infections; Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Severe pulmonary function impairment

  Measured by spirometry

  2 years

Secondary Outcomes (1)

• Changes in impairment of pulmonary function

  2 years

Interventions

No Intervention, and Observational Study OTHER

Observational Study

Also known as: Observational Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This will be a multi-country, multi-centre observational cohort study, conducted at four recruiting sites in four African countries: 1) University of the Witwatersrand (WITS), Johannesburg in South Africa; 2) NIMR-Mbeya Medical Research Center (NIMR-MMRC), Mbeya in Tanzania; 3) Instituto Nacional de Saúde (INS), Ministry of Health, Mozambique; 4) Medical Research Council (MRC) Unit The Gambia, Fajara, The Gambia.

You may qualify if:

• At least one sputum sample tested positive for Mtb by Xpert MTB/RIF assay in the study clinic/study laboratory or at least one sputum sample tested positive by culture methods in study laboratory or other TB laboratory
• Be ≥ 18 years of age
• Willingness to provide a written consent or witnessed oral consent in the case of illiteracy for participation in the study, prior to patient's first sample or other study-specific data being collected
• Willing to be tested for HIV infection
• Agrees to the collection and storage of blood, urine, and sputum specimens for use in future research
• Willing to start anti-TB treatment after TB diagnosis
• Living within the study area and willing to inform the study team of any change of address during the treatment and follow-up period

You may not qualify if:

• Has received TB treatment in the last 6 months
• Has incapacity to produce and provide two sputum samples of sufficient quality (3 ml)
• Has severe medical or psychiatric condition which in the opinion of the site investigator or designee, might interfere with the ability to give true informed consent and to adhere to the study requirements
• Is currently imprisoned
• Taking part in investigational product trials related to TB and/or lung diseases

Sponsors & Collaborators

• The Aurum Institute NPC: lead
• Ludwig-Maximilians - University of Munich: collaborator
• Research Center Borstel: collaborator
• University of Witwatersrand, South Africa: collaborator
• Mbeya Medical Research Centre NIMR: collaborator
• Ministry of Health Instituto Nacional de Saude: collaborator
• Medical Research Council Unit, The Gambia: collaborator
• Karolinska Institutet: collaborator

Study Sites (4)

Instituto Nacional de Saúde

Maputo, Mozambique

Location

The Clinical HIV Research Unit

Johannesburg, Gauteng, 2092, South Africa

Location

NIMR-Mbeya Medical Research Centre

Mbeya, Tanzania

Location

The MRC-Unit

Fajara, The Gambia

Location

Related Publications (1)

• Rachow A, Ivanova O, Wallis R, Charalambous S, Jani I, Bhatt N, Kampmann B, Sutherland J, Ntinginya NE, Evans D, Lonnroth K, Niemann S, Schaible UE, Geldmacher C, Sanne I, Hoelscher M, Churchyard G. TB sequel: incidence, pathogenesis and risk factors of long-term medical and social sequelae of pulmonary TB - a study protocol. BMC Pulm Med. 2019 Jan 7;19(1):4. doi: 10.1186/s12890-018-0777-3.

  PMID: 30616617 DERIVED

Related Links

• TB Sequel Website

Biospecimen

Retention: SAMPLES WITH DNA

Collection Bloods, Urine and Sputum will be obtained from each patient at different time-points for analysis and storage. They will include, but are not limited to: native urine, native sputum, extracted DNA from positive liquid culture, sputum pellet and surpernatant and whole blood (PAXgene, plasma, serum, PBMC).

MeSH Terms

Conditions

Respiratory Tract Infections; Tuberculosis, Pulmonary

Interventions

Observation

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Lung Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Gavin J Churchyard

  Chief Executive Officers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 16, 2017
• Study Start: September 22, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

TA (1); TH (1); MO (1); ZA (1)